PMA P200035S036

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S036
Product code: QQK
Decision date: 2026-04-10
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: including additional bioburden and bacterial endotoxin testing for the oxygenator component of the D0146/D0146-US Disposable Set

Current openFDA PMA Record#

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S036
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2026-04-10
Decision code: APPR
Date received: 2026-03-13
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: including additional bioburden and bacterial endotoxin testing for the oxygenator component of the D0146/D0146-US Disposable Set